DESREM POWDER

País: África do Sul

Língua: inglês

Origem: South African Health Products Regulatory Authority (SAHPRA)

Disponível em:

Mylan Pharmaceuticals (Pty) Ltd

Dosagem:

100,0 mg

Forma farmacêutica:

POWDER

Composição:

EACH VIAL CONTAINS REMDESIVIR 100,0 mg

Status de autorização:

Registered

Folheto informativo - Bula

Mylan (Pty Ltd Injection, 100 mg/vial
DESREM
Remdesivir
03 October 2023
Signature
Page 1 of 8
1.3.2 PROPOSED CLEAN PIL
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4 DESREM 100 MG/VIAL
LYOPHILIZED POWDER FOR INJECTION FOR LV INFUSION
REMDESIVIR
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DESREM
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or
other health care provider.
_ _
WHAT IS IN THIS LEAFLET
1.
What DESREM is and what it is used for
2.
What you need to know before you use DESREM
3.
How to receive DESREM
4.
Possible side effects
5.
How to store DESREM
6.
Contents of the pack and other information
1.
WHAT DESREM IS AND WHAT IT IS USED FOR
DESREM contains the active substance remdesivir. It is an antiviral
medicine used
for treating COVID-19.
Mylan (Pty Ltd Injection, 100 mg/vial
DESREM
Remdesivir
03 October 2023
Signature
Page 2 of 8
COVID-19 is caused by a virus called a coronavirus. DESREM stops the
virus
multiplying in cells and this stops the virus multiplying in the body.
DESREM will be given to people with COVID-19. DESREM It is suitable
for adults.
It will only be given to patients who have pneumonia, and need extra
oxygen to
help them breathe.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DESREM
DESREM SHOULD NOT BE ADMINISTERED TO YOU:
•
if you are hypersensitive (allergic) to remdesivir or any of the other
ingredients
of DESREM (listed in section 6). _ _
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before starting treatment with DESREM:
•
if you have liver problems. Some people developed increased liver
enzymes
when given DESREM. Your doctor will do blood tests before starting
treatment
to check whether you can be given it safely.
•
if you have kidney problems. People with severe kidney problems will
not be
given this medicine. Your doctor will do blood tests to check whether
you can
be given it safely.
_REACTIONS FOLLOWING THE INFUSION _
DESREM
can
cause
allergic
reactions
or

Características técnicas

Mylan (Pty Ltd Injection, 100 mg/vial
DESREM
Remdesivir
03 October 2023
Signature…………….…….
Page 1 of 19
1.3.1.1 PROPOSED PI PROFESSIONAL INFORMATION
SCHEDULING STATUS
S 4
1
NAME OF THE MEDICINE
DESREM 100 mg/vial Lyophilized Powder for Injection for lV Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of remdesivir.
Each ml of concentrate contains 5 mg of remdesivir.
DESREM 100 mg vial contains 3 g sulfobutylether-β-cyclodextrin sodium
salt
(SBECD). For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lyophilized powder for injection for lV infusion.
White to off-white to yellow lyophilized powder or lumps or solid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DESREM is indicated for the treatment of coronavirus disease 2019
(COVID-19)
in adult patients with pneumonia requiring supplemental oxygen (see
section 5.1). _ _
Mylan (Pty Ltd Injection, 100 mg/vial
DESREM
Remdesivir
03 October 2023
Signature…………….…….
Page 2 of 19
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Use of DESREM is confined to healthcare facilities in which patients
can be
monitored closely (see section 4.4).
POSOLOGY
The recommended dosage of DESREM is:
• Day 1 – single loading dose of DESREM 200 mg given by
intravenous infusion.
• Day 2 onwards – 100 mg given once daily by intravenous infusion.
The total duration of treatment should be at least 5 days and not more
than 10
days.
SPECIAL POPULATIONS
_ELDERLY _
No dose adjustment of DESREM is required in patients over the age of
65 years
(see sections 5.1 and 5.2).
_RENAL IMPAIRMENT _
The pharmacokinetics of remdesivir have not been evaluated in patients
with renal
impairment.
Patients
with eGFR ≥
30 ml/min
have
received
remdesivir
for
treatment of COVID-19 with no dose adjustment. DESREM should not be
used in
patients with eGFR < 30 ml/min (see sections 4.4 and 5.2).
_HEPATIC IMPAIRMENT _
The pharmacokinetics of remdesivir have not been evaluated in patients
with
hepatic impairment. It is not known if dosage